Spherix starts patient recruitment in India for phase 3 diabetes trial
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Spherix Incorporated reported that patient recruitment for its Phase 3 clinical trial of its potential type 2 diabetes drug, Naturlose, has begun in India. Expectations for India are to provide more than 300 patients spread across 35 sites for the pivotal Phase 3 trial.
“Now that enrollment efforts are underway in India, we believe that the Phase 3 trial will be completed on schedule as reported during the May 2008 Annual Shareholders Meeting. This truly represents a tremendous amount of hard work, both internally and externally, to achieve regulatory approval and patient recruitment in such a short period of time,” said Randy W. Brown, Chief of Operations. Global enrollment is scheduled for completion by the end of the first quarter 2009, and the trial is scheduled to be completed in 2010.
Spherix Incorporated also announced the signing of a contract with Amarex, a Contract Research Organization (CRO) located in Germantown, MD, to oversee the work of two India CROs hired to execute the trial in India.
“It became quite clear that the trial was not executable solely in the United Sates with our known parameters; therefore, India became an obvious, viable solution. I now expect our ultimate deliverable, a new drug application, to be back on schedule,” said Mr. Brown.
Certain statements contained herein are “forward looking” statements as defined in the Private Securities Litigation Reform Act of 1995. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied. Factors that could cause actual results to differ materially from those expressed or implied include, but are not limited to, those discussed in filings by the Company with the Securities and Exchange Commission, including the filing on Form 8-K made on October 10, 2007.
Spherix’s mission is to create value and increase shareholder wealth through innovations that benefit our clients and the human condition. Spherix offers innovations in biotechnology, and provides technical and regulatory consulting services to biotechnology and pharmaceutical companies.
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